The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Synsonic Ulna Nail.
| Device ID | K131984 |
| 510k Number | K131984 |
| Device Name: | SYNTHES SYNSONIC ULNA NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Thomas N Shea |
| Correspondent | Thomas N Shea SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2014-03-31 |
| Summary: | summary |